LTV 1000 VENTILATOR

K051767 · Pulmonetic Systems, Inc. · CBK · Jul 29, 2005 · Anesthesiology

Device Facts

• Record ID: K051767
• Device Name: LTV 1000 VENTILATOR
• Applicant: Pulmonetic Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The LTV ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control, SIMV, or CPAP modes of ventilation. - Breath types including Volume, Pressure Control and Pressure Support. The ventilator is suitable for use in institutional, home and transport settings.

Device Story

LTV 1000 is a continuous/intermittent ventilator for institutional, home, and transport use. Modification adds Spontaneous Breathing Trial (SBT) function to assist weaning. Clinicians input CPAP parameters and alarm settings via menu; device executes trial for 15-120 minutes. Informational alarms trigger at two minutes remaining and at trial conclusion. Upon completion, ventilator reverts to previous mode/settings. Operated by trained personnel under physician direction. Output provides ventilatory support and weaning data to inform clinical decisions regarding patient readiness for extubation/weaning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Continuous ventilator; supports invasive/non-invasive positive pressure ventilation. Software-based modification adds SBT menu presets for CPAP parameters and alarm timing. Connectivity/materials not specified. Operates in institutional, home, and transport settings.

Indications for Use

Indicated for adult and pediatric patients weighing at least 5 kg (11 lbs) requiring continuous or intermittent mechanical ventilatory support via invasive (ET tube) or non-invasive (mask) positive pressure ventilation, including Assist/Control, SIMV, or CPAP modes with Volume, Pressure Control, or Pressure Support breath types.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• LTV 1000 Ventilator (K981371, K984056, K002881, K010608, K032226)
• Engstrom Carestation (K041775)

Submission Summary (Full Text)

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K051767

'JUL 2 9 2005

## 510(K) SUMMARY 1.

### SUBMITTER 1.1

Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341

| Contact Person: | Robert C. Samec | |
|-----------------|-----------------|-----------|
| | [phone] | Telephone |
| | [phone] | Facsimile |

### 1.2 DEVICE / TRADE NAME

Trade Name: LTV 1000 Ventilator

Common Name: Ventilator

Classification Name: Ventilator, Continuous (Respirator) 868.5895

### SUBMISSION DATE 1.3

Submission Date: June 28, 2005

### DESCRIPTION 1.4

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
- . Assist/Control, SIMV, or CPAP modes of ventilation.
- Breath types including Volume, Pressure Control and Pressure Support. .

The modification intended to be cleared by this submission is:

- The addition of Spontaneous Breathing Trial (SBT) function allowing the clinician to . more easily determine a patient's ability to be weaned from ventilation.

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### 1.5 INTENDED USE

The LTV ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively . (via mask).
- . Assist/Control, SIMV, or CPAP modes of ventilation.
- Breath types including Volume, Pressure Control and Pressure Support. ●

The ventilator is suitable for use in institutional, home and transport settings.

### 1.6 EQUIVALENCE TO PREDICATE DEVICE(S)

The LTV 1000 Ventilator listed modifications are substantially equivalent to the following listed devices:

| Predicate Device | 510(k) Clearance | Manufacturer |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| LTV 1000 Ventilator | K981371 - Initial clearance for<br>Institutional and Transport<br>settings.<br>K984056 - Homecare settings.<br>K002881 - Enhancements.<br>K010608 - Lap Top Monitor.<br>K032226 - 5 kg Patient Application. | Pulmonetic Systems, Inc.<br>Colton, CA/Mpls., MN |
| Engstrom<br>Carestation | K041775- Initial clearance | GE Datex-Ohmeda |

The LTV 1000 ventilator, previously cleared for homecare use and for institutional and transport settings, is now being submitted for clearance with the listed modification.

The table on the following pages compares the modification/feature of the LTV to the previously cleared LTV 1000 ventilator

The LTV 1000 ventilator with the modification listed is substantially equivalent to the predicate LTV 1000 (K032226) and the Engstrom Carestation (K041775).

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| Characteristic<br>(LTV Modification)<br>Spontaneous Breathing (SBT) | LTV 1000<br>(Predicate Device) | Engstrom Carestation<br>(Predicate Device) | Discussion of Differences and<br>Similarities |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinicians manually set the CPAP<br>mode/parameters and alarm<br>parameters to start breathing<br>trials. An informational alarm will<br>appear with two minutes left in<br>the study and when the trial has<br>ended. At trial end, the ventilator<br>will return to the previous mode<br>and settings. | Clinicians manually set the CPAP<br>mode/parameters and alarm<br>parameters to start breathing<br>trials. An informational alarm will<br>appear with two minutes left in<br>the study. At trial end, the<br>ventilator will return to the<br>previous mode and settings. | The software application to allow<br>input presets for CPAP<br>mode/parameters and alarm<br>parameters is an addition to the<br>existing LTV 1000 preset menu<br>options and does not introduce<br>any additional or new patient risk<br>or involve the application of new<br>technology. |
| | SBT time duration available by<br>menu selection (15-120 minutes) | SBT time duration available by<br>menu selection (5-60 minutes) | Longer time duration is provided<br>at the request of clinicians. |

# SUBSTANTIAL EQUIVALENCE SUMMARY TABLE

The LTV 1000 ventilator with the modification listed is substantially equivalent to the predicate LTV 1000 (K03226) and
Engstrom Carestation (K041775).

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.

JUL 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert C. Samec Pulmonetic Systems, Incorporated 17400 Medina Road Suite 100 Minneapolis, Minnesota 55447-1341

Re: K051767

Trade/Device Name: LTV 1000 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator Regulatory Class: II Product Code: CBK Dated: June 28, 2005 Received: June 30, 2005

Dear Mr. Samec:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Samec

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Ventilator, Continuous (Respirator)

Indications for Use:

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support:

- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
- Assist/Control, SIMV, or CPAP modes of ventilation. ●
- Breath types including Volume, Pressure Control and Pressure Support. ●

The ventilator is suitable for use in institutional, home, or transport settings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aue Sullion

hesiology, General Hospital.

510(k) Number: K051767

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